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CEP/COS
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Europe
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 25MG **Federal Registe...DOSAGE - TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12427
DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12427
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ABOUT THIS PAGE
81
PharmaCompass offers a list of Benzphetamine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Benzphetamine manufacturer or Benzphetamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benzphetamine manufacturer or Benzphetamine supplier.
PharmaCompass also assists you with knowing the Benzphetamine API Price utilized in the formulation of products. Benzphetamine API Price is not always fixed or binding as the Benzphetamine Price is obtained through a variety of data sources. The Benzphetamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Benzphetamine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzphetamine HCl, including repackagers and relabelers. The FDA regulates Benzphetamine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzphetamine HCl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Benzphetamine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benzphetamine HCl supplier is an individual or a company that provides Benzphetamine HCl active pharmaceutical ingredient (API) or Benzphetamine HCl finished formulations upon request. The Benzphetamine HCl suppliers may include Benzphetamine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Benzphetamine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzphetamine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzphetamine HCl active pharmaceutical ingredient (API) in detail. Different forms of Benzphetamine HCl DMFs exist exist since differing nations have different regulations, such as Benzphetamine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzphetamine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Benzphetamine HCl USDMF includes data on Benzphetamine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzphetamine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzphetamine HCl suppliers with USDMF on PharmaCompass.
A Benzphetamine HCl written confirmation (Benzphetamine HCl WC) is an official document issued by a regulatory agency to a Benzphetamine HCl manufacturer, verifying that the manufacturing facility of a Benzphetamine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benzphetamine HCl APIs or Benzphetamine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Benzphetamine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Benzphetamine HCl suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Benzphetamine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Benzphetamine HCl API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Benzphetamine HCl as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Benzphetamine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Benzphetamine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Benzphetamine HCl suppliers with NDC on PharmaCompass.
Benzphetamine HCl Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Benzphetamine HCl GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Benzphetamine HCl GMP manufacturer or Benzphetamine HCl GMP API supplier for your needs.
A Benzphetamine HCl CoA (Certificate of Analysis) is a formal document that attests to Benzphetamine HCl's compliance with Benzphetamine HCl specifications and serves as a tool for batch-level quality control.
Benzphetamine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Benzphetamine HCl CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Benzphetamine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Benzphetamine HCl EP), Benzphetamine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benzphetamine HCl USP).
